The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization.
To meet the objective and execute the deliverables for this program of effort, the A\&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings.
Goals:
1. Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A\&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.
Asymptomatic and symptomatic individuals 18 years and older
Receiving standard COVID-19, Flu and/or RSV screening and testing at BAMC
Do not have to be diagnosed with SARS-CoV-19 (COVID-19) but only be screened
Ability to understand consent
Any individual under age of 18
Anyone unable to comply (or be assisted) with study procedures
Anyone not able to provide temperature thermal scan, and/or perform exhaled breath for approximately 8 seconds
Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19, Flu and/or RSV screening and testing at BAMC, with and without COVID-19.
Case-control
Prospective
A&M Breathalyzer PROTECT Kiosk
DeviceThe A\&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan thresholds and sensitivity data.
Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk
Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, to test its detection capabilities of COVID-19, Flu, and/or RSV among symptomatic and asymptomatic COVID-19, Flu or RSV carrier vs. those not infected compared to gold standard RT-PCR.
Concentration on evaluating the passive sensing, breath capture system built within the A&M Breathalyzer PROTECT Kiosk.
This evaluation would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.
Click on the lead sponsor to view all of their trials.
The Geneva Foundation
Lead sponsor
Brooke Army Medical Center
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
Level 42 AI, Inc.
Collaborator
